Gilead Sciences has faced years of allegations that it sidelined its safer, next-gen HIV drugs to reap as much revenue as possible from the older generation before the new meds hit. And a federal judge has allowed one set of those allegations—filed by 140 patients from 31 states—to proceed.
The lawsuit claims Gilead shelved candidates based on tenofovir alafenamide fumarate (TAF) back in 2004 to protect an older franchise based on tenofovir disoproxil fumarate (TDF)—despite the fact that it knew the TAF-based meds were safer.
Because of that delay, patients who took the TDF meds needlessly developed kidney and bone problems associated with the older drugs, which require much higher doses than the TAF-based regimens do, the suit says.
Gilead’s TDF meds Viread, Truvada, Atripla, Complera and Stribild won FDA approvals in 2001, 2004, 2006, 2011 and 2012, respectively. The safer TAF meds hit the market beginning with Genvoya in 2015, followed by Odefsey and Descovy in 2016.
When it launched the newer suite of meds, Gilead touted TAF's safety—particularly its lower risks of kidney and bone toxicities—to convince doctors to move patients to the next-gen products. Its switching campaign depended on "the very benefits that Gilead could have and should have incorporated into its prior product designs but withheld from doctors and patients for over a decade,” the lawsuit claims.
Gilead had the chance to pursue TAF but discontinued development way back in 2004, claiming that it was too similar to TDF research, the lawsuit says. But in truth, the plaintiffs say, the company saw an advantage for pursuing two separate periods of exclusivity for the meds.
A Gilead spokesman said that "for nearly three decades, Gilead has been committed to developing and improving upon therapies that address unmet needs for people living with HIV."
"Ongoing collaboration with, and input from, the medical and advocacy communities have always played a key role in helping inform our development programs and decisions," he added. "Patient safety is of foremost importance to us. Gilead believes these lawsuits are without merit and we intend to defend against the claims."
If the allegations sound familiar, it's likely because Gilead has faced similar accusations several times before. Previously, the AIDS Healthcare Foundation (AHF) leveled similar allegations, but on anticompetitive grounds; Gilead prevailed in the case.
Now, plaintiffs are alleging they unnecessarily suffered complications from TDF drugs because of Gilead's strategy. The suit brings claims of design defects, failure to warn, negligence, product liability and more. A similar lawsuit brought by California residents Michael Lujano and Jonathan Gary is progressing in state court.
Gilead had asked the federal court to dismiss the suit on several grounds. The company argued that federal law preempts the patients' claims, that the plaintiffs didn't have adequate backing to show its drugs caused the patients' side effects and that the company had no duty to launch TAF drugs earlier than it did, based on the court's decision in the AHF case.
After reviewing the arguments, Judge Jon Tigar in the U.S. District Court for the Northern District of Illinois allowed most of the plaintiffs’ claims to proceed. Gilead did succeed in getting some claims tossed, but the judge gave the plaintiffs until May 31 to restate their allegations in an amended lawsuit.